MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-14 for HOT COLD WATER BOTTLE 02814WG2 manufactured by Apothecary Products, Llc.
[136232945]
The incident was reported to apothecary products over a year later and the suspected device was not available for evaluation. Apothecary products test and inspect evering incoming lot of this product and have conducted a thorough internal investigation on the water bottles.
Patient Sequence No: 1, Text Type: N, H10
[136232946]
The customer stated they filled the hot-cold water bottle with tap water and experienced second degree burns after placing the bottle over clothing on their back. The customer sought treatment at a medical facility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002183416-2019-00002 |
| MDR Report Key | 8341339 |
| Date Received | 2019-02-14 |
| Date of Report | 2019-02-14 |
| Date of Event | 2017-10-15 |
| Date Mfgr Received | 2018-12-18 |
| Date Added to Maude | 2019-02-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PAXIA HER |
| Manufacturer Street | 11750 12TH AVE S |
| Manufacturer City | BURNSVILLE MN 55337 |
| Manufacturer Country | US |
| Manufacturer Postal | 55337 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HOT COLD WATER BOTTLE |
| Generic Name | HOT COLD THERAPY WATER BOTTLE |
| Product Code | FPF |
| Date Received | 2019-02-14 |
| Model Number | 02814WG2 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APOTHECARY PRODUCTS, LLC |
| Manufacturer Address | 11750 12TH AVE S. BURNSVILLE 55337 US 55337 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-02-14 |